What statement should be included in medical notes when discussing supplements, regarding their lack of regulation by the Food and Drug Administration (FDA) and the importance of third-party verification for credibility?

From the Guidelines

When discussing supplements with patients, it is essential to inform them that dietary supplements are not regulated by the FDA for safety or efficacy prior to marketing, and therefore, it is crucial to look for third-party verification labels such as USP, NSF, ConsumerLab, or Informed-Choice. This recommendation is based on the most recent and highest quality study available, which highlights the importance of third-party verification in ensuring the quality, purity, and accurate labeling of supplements 1. The study emphasizes that the use of complementary products poses a challenge to clinicians, and the lack of regulation by the FDA increases the risk of adverse effects and interactions with other medications. Key points to consider when discussing supplements with patients include:

• The difference in regulation between dietary supplements and prescription medications
• The importance of third-party verification labels in ensuring supplement quality and safety
• The potential risks and interactions associated with supplement use
• The need for patients to be aware of these risks and take an active role in selecting high-quality supplements. As noted in the study, patients often believe that supplements are safer than prescription medications because they are "natural," but this is not necessarily the case 1. By informing patients about the lack of FDA regulation and the importance of third-party verification, healthcare providers can help patients make informed decisions about supplement use and reduce the risk of adverse effects. It is also important to note that the regulatory framework for supplements varies between countries, and healthcare providers should be aware of the specific regulations in their region 1. However, the recommendation for third-party verification remains a crucial aspect of ensuring supplement safety and quality, regardless of the regulatory framework.

From the Research

Disclosure of Supplement Regulation

When discussing supplements in medical notes, it is essential to disclose that supplements are not FDA regulated. According to 2, the FDA can remove a supplement from the market for various reasons, but the agency does not regulate supplements in the same way as pharmaceuticals.

Importance of Third-Party Verification

To ensure credibility, patients should look for third-party stamps or labels on supplement products. This is because the quality and safety of supplements can be highly variable, especially for botanical and herbal products, as noted in 3.

Key Points to Include in Medical Notes

When discussing supplements, the following points should be included in medical notes:

• Supplements are not FDA regulated
• Patients should look for third-party stamps or labels to ensure credibility
• The quality and safety of supplements can be highly variable
• Certain types of supplements, such as those for sexual enhancement, weight loss, and sports performance, are more prone to medical problems, as mentioned in 2
• Clinicians should be aware of potential interactions between supplements and prescription medications, as well as the potential for supplements to cause harm, as discussed in 4